The description of most preferred embodiment
Fig. 1 shows a collection blood assembly 10.In the embodiment shown, assembly 10 by means of traditional centrifugation technique in order to separate and to store red blood cell and blood plasma and blood platelet composition.Assembly 10 is also in order to remove unwanted material from red blood cell before storage.In the embodiment shown, unwanted material is by removing by filter.
Just as used herein, vocabulary " filtration " is intended to comprise by various centrifugal and separating that non-centrifugation technique is realized, but not only is " filtration " on the technical meaning.Can be by means of absorption, post, chemistry, electronics is realized separating with calutron.So, adopted vocabulary " filtration " in this manual widely to contain all these isolation technics.
In most preferred embodiment shown in Figure 1, assembly 10 comprises a main bag or container 12 and several transfusion bags or container 14,16 and 18.Main bag 12 comprises a bloodletting tube 22 of installing integratedly, and this bloodletting tube 22 is equipped with a venous needle 24.
Arm 20 will be led bag 12 and be connected in transfusion bags 14,16 and 18 integratedly.Pipe 20 is divided into arm 20A, 20B, 20D and 20E.
In the embodiment shown, assembly 10 is included in arm 20A, 20B, 20C, the pipeline inner fluid flow control apparatus 26,28,30 and 32 among 20D and the 20E.Shown in the scheme, these flow control apparatus are got the form of traditional frangible cannula.Each intubate stops the fluid relative arm of flowing through usually.When with hand when crooked, the intubate branch is split and open relevant arm.
In the embodiment shown, intubate 26 controls are flowed through the fluid of arm 20A, and intubate 28 controls are flowed through the fluid of arm 20B.Intubate 30 controls are flowed through the fluid of arm 20C and 20D.Intubate 32 controls are flowed through the fluid of arm 20E.
Shown in and illustrated embodiments, main bag 12 has a top and bottom opening structure, with described and claimed similar of the United States Patent (USP) 4,608,178 of Johansson etc.One commercialization embodiment of this system is sold with the trade mark of OPTI-SYSTEM by Baxter Healthcare Corporation (FenwalDivision).Should be appreciated that as another kind of and select that all openings relevant with main bag can be provided with along the top of bag, this also is the traditional structure of blood bag.
In ad hoc structure shown in Figure 1, bag 12 comprises two bottom openings 34 and 36 and open tops 38.Arm 20B is communicated with bottom opening 34.Bloodletting tube 22 is communicated with bottom opening 36.Arm 20A is communicated with open top 38.
In the embodiment shown, main bag 12 and transfusion bags 14 and 18 comprise commonly sealed operation aperture 41.Opening 41 is sealed in traditional tearing in the sheet.When opening, tear sheet opening 40 is exposed, so that traditional blood transfusion or carrier pipe (not shown) to be installed.
In use, the bloodletting tube 22 that connects by one of main bag 12 is accommodated the whole blood (shown in the arrow among Fig. 1) from a blood donor.Main bag 12 comprises suitable anticoagulant A.
Complete blood will separate by centrifugal action in main bag 12.Centrifugal action is separated into various cells and acellular composition with whole blood.
In use, transfusion bags 14 is intended to hold by arm 20A the plasma fraction of main bag 12 collected whole blood.Transfusion bags 14 final reservoir vessels as plasma fraction.
According to the specific purpose of blood processing program, plasma fraction can roughly carry all blood platelets relevant with collected whole blood, and in this case, this composition will be called as " platelet rich plasma " or PRP.Select as another kind, plasma fraction can be substantially free of blood platelet, and in this case, this composition is called as " platelet poor plasma " or PPP.
In the embodiment shown, transfusion bags 16 contains a kind of storage solutions S, and this storage solutions is red blood cell (RBC) composition that is used for main bag 12 collected whole blood.A kind of this class solution is disclosed in the United States Patent (USP) 4,267,269 of Grode etc.Another kind of this class solution is called as " SAGM " solution traditionally.
In use, transfusion bags 16 is accommodated isolated RBC composition through arm 20B.Isolated RBC composition mixes with storage solutions S in bag 16.Therefore, transfusion bags 16 also can be called as " mixed bag ".
Arm 20C and 20D form a flow path together between transfusion bags 16 and transfusion bags 18.Arm 20D is communicated with transfusion bags 18 by the first opening P1.
This arm 20D comprises an interior lines separator 40, in order to separate unwanted material from blood cell.Separator 40 comprises an inlet 46 and one outlet 48.
In use, transfusion bags 18 accommodate by after the separator 40 through the RBC composition (S mixes with storage solutions) of the first opening P1.Transfusion bags 18 final reservoir vessels as the RBC composition.
The available medical grade plastic material manufacturing of approval traditionally of bag relevant with processing components 10 and pipe is for example with the polyvinyl chloride of two (2-ethylhexyl) phthalate (DEHP) plasticising.As shown in Figure 1, can adopt traditional " T " or " Y " joint 39,, form the fluid flow path of bifurcated between 20D and the 20E with at arm 20C.
Assembly 10 shown in Figure 1 is in case by sterilization treatment, be aseptic " closed " system with regard to constituting an application standard by the U.S..Assembly 10 still keeps " sealing " during handling.This just guarantees can adopt the longest regulation storage time to collected composition.
Select as another kind, assembly 10 is preferably in and comprises one group of bactericidal unit at the very start.For example, main bag 12 can comprise a bactericidal unit, and transfusion bags 14 comprises another bactericidal unit, and transfusion bags 16 also comprises another bactericidal unit, and separator 40 and transfusion bags 18 also comprise another bactericidal unit.(not shown) in this scheme, arm 20A, 20B and 20C will be equipped with the sterilization jockey that matches that the user links together in use, so that form a single one assembly 10 shown in the drawings.In the United States Patent (USP) 4,157,723 and 4,265,280 of Granzow etc. the sterilization jockey that is adopted for this purpose has been shown.
In first treatment step, complete blood is in bloodletting tube 22 is collected in main bag 12 (as shown in Figure 1).Then system 10 is put into 50 (as shown in Figure 6) of basket of a traditional blood centrifugal machine as a black box.
To make basket 50 rotations at a high speed, be separated into red blood cell (RBC) composition and PRP or PPP plasma fraction with the whole blood that will lead by centrifugal action in the bag 16.
Separation process is to produce PRP or PPP plasma fraction, depends on rotary speed and time in the processing.In a preset time, produce PPP than low-rotate speed (being called-" soft " rotation).Interior at one time higher rotation speed (being called-" firmly " rotation) produces more blood platelets in blood plasma, promptly produce PRP.
As shown in Figure 2, there is main bag 12 bottom in heavier RBC composition during handling.There is the top of main bag 12 in lighter PRP/PPP plasma fraction during handling.
During centrifugation, between red blood cell composition and PRP/PPP plasma fraction, be formed with a leukocytic intermediate layer (often be called " yellowish chromatograph " and represent with BC) at Fig. 2.If plasma fraction is PPP, yellowish chromatograph also comprises a large amount of blood platelets.If plasma fraction is PRP, almost not remaining in yellowish chromatograph has blood platelet.
After step with centrifugal separation, user's extraction system 10 and begin the 3rd treatment step (as shown in Figure 2) from centrifugal basket 50.In this step, the user makes intubate 26 with hand and split in 28 minutes.Between two plates that separate 52, push then or the main bag 12 of pushing.This extruding action is extruded the PPR/PPP composition simultaneously from the open top 38 of bag 12, and simultaneously the RBC composition is extruded from the bottom opening 36 of bag 12.Yellowish chromatograph BC then still stays in the bag 12.
The U.S. Patent No. 4,350,585 of Johansson etc. discloses a system, has the plate 52 of the main bag 12 of extruding, extrudes blood plasma and RBC composition with top and the bottom opening 36 and 38 from bag 12 simultaneously.One commercialization embodiment of this type systematic is sold with the trade mark of OPTIPRESS by Baxter Healthcare company (Fenwal Division).
As shown in Figure 2, when bag 12 was pushed by plate, the PRP/PPP plasma fraction flowed into blood transfusion/reservoir bag 14 through arm 20A.Simultaneously, the RBC composition flows into transfusion bags 16 through arm 20B, and it mixes with storage solutions S at this.
By when main bag 12 is extruded, this technology keeps yellowish chromatograph (BC) to be clipped between PRP/PPP composition and the RBC composition at mentioned component.This technology with yellowish chromatograph and thereupon together most of white blood cell be retained in the main bag 12, to carry out collection and processing subsequently.Leukocytic quantitative aspects in PRP/PPP plasma fraction and RBC composition is compared with the white blood cell in being included in whole blood, and this technology can realize about 0.75 to about 1.00log decline.
As shown in Figure 3, at the terminal point of second treatment step, transfusion bags 14 (containing the PRP/PPP composition) can be separated with main bag 12 (containing the BC composition) in aseptic mode with transfusion bags 16 (containing the RBC composition that mixes with storage solutions S), independently to handle.
By on arm 20A and 20B, forming card disconnected (snap apart) sealing 54, can realize bag 12,14 and 16 separate.Can adopt a traditional hot sealing device (for example non-conductive sealer of selling by BaxterHealthcare company of He matron) for this purpose.This device forms an airtight disconnected sealing 54 of card in arm 20A and 20B.
Best, before centrifugation, bloodletting tube 22 is also thrown off (shown in Fig. 2 and 3) with the same manner sealing and with main bag 12.
In the 3rd treatment step (as shown in Figure 3), the user further handles the transfusion bags 16 and 18 of separation, arm 20C, 20D and the 20E of separator 40 and interconnection.
In this step, the user is with transfusion bags 16 outstanding blood transfusion reservoir bag 18 tops that are held in.The user fractures intubate 30 so that be communicated with through arm 20C and 20D and separator 40 between transfusion bags 16 and the blood transfusion/reservoir bag 18.Under the gravity effect, RBC composition (S mixes with storage solutions) flows into transfusion bags 18 through separator 40 by opening P1.
Best, adopt separator 20 from the RBC composition, to remove all types of materials that do not need, this depends on its ad hoc structure, in the embodiment shown, separator 40 is removed white blood cell before being intended to store from the RBC composition.
In this scheme (as Fig. 7), separator 40 comprises a shell 42, and it contains and be suitable for removing leukocytic traditional fibre shape filter medium 44 from red blood cell.Filter medium can comprise wool, other synthetic fibers of cellulose acetate or polyester and so on.Removing from the RBC composition by separator 40 does not need material (being white blood cell).
So the 3rd treatment step has been done to replenish to the separation of front and extrusion process (as shown in Figure 2) to remove white blood cell from the RBC composition.What separator 40 had replenished main bag 12 tops and bottom opening structure removes white blood cell efficient.During the processing, leukocytic quantitative aspects in the RBC composition adopts separator 40 can realize other 0.5 to about 1.0log decline.
The bag 16 that is an integrally closed system part is not ventilated with atmosphere.In addition, bag 16 preferably only contains the relatively limited surplus air of volume.Along with the whole liquid volume of RBC composition (and solution S) is discharged from bag 16, and along with limited surplus air volume is drained, the sidewall of bag 16 will inwardly subside gradually, stops through the mobile of separator 40 up to RBC composition (and solution S).This indicates the end of the 3rd treatment step.
As shown in Figure 4, finish the 3rd treatment step flow stop the RBC composition (and solution S) of resid vol is trapped in the separator 40 and in the part of the arm 20D at separator 40 upstream and downstream places.This resid vol has reduced the total quantity that stores and treat the RBC composition of usefulness.
And in a canonical system, blood transfusion/reservoir bag 18 to the 3rd treatment steps finish to contain 40 cubic centimetres the surplus air of having an appointment.About 20 cubic centimetres air is original being kept within blood transfusion/reservoir bag 18 before accommodating the RBC composition.Carry RBC compositions (and solution S) that about 20 cubic centimetres more multiresidue air is entered transfusion bags 18 from bag 16 through arm 20C and 20D and separator 40.Before long term storage RBC composition, wish from blood transfusion/reservoir bag 18, to remove surplus air.
Assembly 10 comprises that one the manages step everywhere, to discharge surplus airs from blood transfusion/reservoir bag 18.Assembly 10 also comprises one the 5th treatment step with the guiding surplus air, and the resid vol RBC composition (and solution S) that is detained is moved into blood transfusion/reservoir bag 18.
Manage everywhere (as shown in Figure 4) in the step, the user opens intubate 32.The user is squeeze bag 18 lightly, discharges by the second opening P2 that separates with the first opening P1 through arm 20E with the surplus air that will be trapped in the transfusion bags 18.The flow through second opening P2 and flow into arm 20E of surplus air, this moment, the RBC composition (and solution S) of resid vol occupied separator 40.
Arm 20E derives surplus air bag 18 and walks around separator 40 through opening P2 and imports arm 20C.The air of discharging, the path of following the flow resistance minimum enters bag 16.The surplus air of discharging from bag 18 is collected in the bag 16.
In the 5th treatment step (as shown in Figure 5), the user forms one in the upstream of intubate 32 and blocks disconnected sealing 54 in arm 20E.So just sealed arm 20E, blood transfusion/reservoir bag 18 is separated with arm 20E.
The discharge surplus air that is transfused to bag 16 enters arm 20C and 20D, and they are only surplus open paths of fluid to being communicated with bag 16.Surplus air is with all or most at least RBC composition in mobile arm 20D and the separator 40 resid vol of (with the solution S of mixing).The resid vol of the RBC composition (and solution S) of emitting flows into blood transfusion/reservoir bag 18.
So assembly 10 is discharged from bag 18 surplus air through the second opening P2, with the air trapping of discharging in bag 16.Surplus air is discharged through an opening (opening P2) and a path (arm 20E), and this opening and path be bypass separator 40 not only, also whole blood separate with gatherer process in keep not contacting with blood.
Then, assembly 10 is recycled to the air of discharging the inlet of separator 40 from bag 16.The air of discharging moves residual RBC composition (and solution S) from separator 40 and arm 20D, makes it flow into bag 18 through opening P1, so that store.
Now, can will transfuse blood by forming the disconnected sealing 54 of a card (in Fig. 5 with shown in the dotted line)/reservoir bag 18 is from arm 20D separation, to store the mixture of filtered RBC composition/solution S subsequently.
To transfuse blood/reservoir bag 18 and arm 20D after separating, the user is squeeze bag 18 lightly preferably, with the RBC composition in the mixed bag 18 equably.Be preferably in this step of program and mix, often contain white blood cell (though concentration is very little) than volume is denseer the preceding because found the RBC composition of resid vol.Mixing makes at the white blood cell that concentration is still little in RBC composition (and solution S) between the storage life even.
Shown in Fig. 5 A, still the hermetic unit attached to the exhaust branch pipe 20E on the bag 18 (through opening P2) can be used as a sample cell 72.Use a traditional blood tube stripper, the user can move into bag 18 from managing 72 with surplus air.The user adopts the disconnected sealing 54 of airtight cards that a traditional hot sealing device (for example non-conductive sealer of He mation) separates with the length that forms one or more edges pipe 72 then.
Sample cell 72 keeps a small amount of sample or the sample of one or more institutes blood sampling.Before adopting the RBC composition in output institute, this sample is in order to subsequently cross matching and measure blood donor's blood group.Integratedly attached to the pipe on the bag 18 72 at blood donor's blood sample be stored in and protected one directly to get in touch between the RBC composition of bag in 18.
According to this aspect of the invention, so assembly 10 has formerly only kept blood sample as (being the part of arm 20E) in the part of the pipe of carrying the first contact blood of air.Like this, assembly 10 has just been avoided the chance with a small amount of blood sample in out-of-proportion a large amount of white blood cells (for example may be present among the arm 20D in the early stage of handling as previously mentioned) contaminated samples pipe 72.
In assembly shown in Figure 1 10, during centrifugal treating, separator 40 is still integratedly attached on the assembly 10.As shown in Figure 6, during centrifugal treating, separator 40 is close together with bag 12,14,16 and 18 and occupies centrifugal blood basket 50.
In general (as shown in Figure 6), main bag 12 is positioned at a side of basket, and other 14,16 and 18 in bag leans against opposite side in order.In this scheme, separator 40 is clipped in the basket 50 near main bag 18.
Shown in and illustrated embodiments in (seeing Fig. 6 and 7), in basket 50, carry out during the centrifugal treating, separator 40 is installed within the flexible pouch 56.Bag 56 comprises that is held a pocket 58, and this appearance pocket holds separator 40 with close fit during handling.
As shown in Figure 6, bag 56 preferably is thin flat configuration.It just can obviously not increase the volume and weight that is contained in the article in the basket 50 like this.
Bag 56 the most handy flexible material manufacturings.The hardness of selection material and thickness are to provide the flat configuration of an opposing moderate finite deformation.
In a most preferred embodiment, bag 56 usefulness medical grade plastic materials are made, for example the PL-742 plastic material.Its also available elastomeric material manufacturing, for example silicon rubber.
Can be by one flat plasticity or the required configuration of the bonding one-tenth of elastomeric material be made bag 56.Select as another kind, also can make bag 56 by injection molding.
In the time of in being put in basket, bags 56 have formed a flexibility but still than the interface of rigidity between the adjacent bag 12,14,16 and 18 in separator 40 and basket.By separator 40 being enclosed within the soft appearance pocket 58, ask the bag in the bag 56 protection baskets 50 not direct contact separation device 40 in the centrifugal treating phase.Like this, bag 56 just can protect other bag not to be punctured or to damage during handling.
As shown in Figure 7, bag 56 can comprise that also one extends to the elongated tail end of holding pocket 58 belows and divides 60.In this structure, as shown in Figure 7, when bag 56 leans against on the main bag 12, the overall width of bag 56 and highly just provided surface areas that cover the effective Disengagement zone 62 of main bag 12 overwhelming majority.
In this scheme, when bag 56 leaned against on the Disengagement zone 62, bag 56 can be along with the distortion in the strong centrifugal force opposing district 62 that exists in the basket 50 during handling.
In the embodiment shown, the width of bag 56 is about 3.0 inches, and maximum height is about 5.0 inches.Be about 1/16 inch and be about 1/8 inch at the thickness that holds pocket 56 its sidewalls of part at its thickness of end section.
Bag 56 with these sizes will cover most Disengagement zone of typical 450ml master's bag.The bag of this size has one and highly is effective Disengagement zone 62 of about 4-3/4 inch for about 6 inches wide.
During handling, may need one or more sand pocket 64 to fill the space that is not occupied in the basket 50, as shown in Figure 8 by assembly 10.
In the embodiment shown, sand pocket 64 comprises the sidewall made from flexible medical level plastics 66, as plasticizing PVC.Open type internal volume 68 of sidewall 66 sealings.Duroplasts ball 70 occupies about 1/3rd or 1/2nd of internal volume 68.
Those skilled in the art can obviously find out various variation of the present invention in the scope of claims in the back.